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L-arginine to Reduce Sympathetic Nerve Activity in CKD Patients
Chronic kidney disease (CKD) is associated with a higher risk of cardiovascular disease and death. An overactive sympathetic nervous system in CKD patients is one of the major mechanisms increasing the cardiovascular risks in this patient population. A potential signal driving sympathetic nerve activity (SNA) involves accumulation of the endogenous nitric oxide synthase (NOS) inhibitor asymmetric dimethylarginine (ADMA). ADMA is elevated in CKD and is a strong, independent predictor of future cardiovascular events in these patients. . The goal of this study is to determine whether overcoming the accumulation of endogenous ADMA with acute L-arginine infusion reduces SNA in CKD patients.
Conditions:
🦠 Chronic Kidney Disease
🗓️ Study Start (Actual) 1 February 2018
🗓️ Primary Completion (Estimated) 31 December 2024
✅ Study Completion (Estimated) 31 December 2024
👥 Enrollment (Estimated) 15
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE4
Locations:
📍 Newark, Delaware, United States
📍 Dallas, Texas, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * CKD patients classified as Stage 3 and 4 of National Kidney Foundation Classification with estimated glomerular filtration rate (GFR) between 15 and 59 mL/min/1.73 m2 according to the Modification of Diet in Renal Disease (MDRD) formula based on serum creatinine, age, gender, and race.
    • * Men and women 35 to 75 years of age

    Exclusion Criteria:

    • * myocardial infarction
    • * heart failure
    • * anemia (hemoglobin \<8 g/dl)
    • * cancer with current treatment
    • * previous organ transplantation
    • * immunosuppressant therapy
    • * human immunodeficiency virus infection
    • * pregnancy and/or lactating
    • * current tobacco use
    • * taking menopausal drugs (estradiol)
    • * treatment for diabetic neuropathy
    • * resting heart rate ≥ 100 bpm and
    • * systolic blood pressure ≤ 90 mmHg
Ages Eligible for Study: 35 Years to 75 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 6 June 2019
  • First Submitted that Met QC Criteria 10 June 2019
  • First Posted 11 June 2019

Study Record Updates

  • Last Update Submitted that Met QC Criteria 14 January 2024
  • Last Update Posted 17 January 2024
  • Last Verified January 2024
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